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Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding (TAVA)

Primary Purpose

Bleeding, Hemoptysis

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Tranexamic acid
Adrenaline
Sponsored by
Clinical Hospital Centre Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring Bronchoscopy, Tranexamic acid, Adrenaline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°C) normal saline (3 aliquots of 5ml during 60sec)

Exclusion Criteria:

  • Any patient with a contraindication for diagnostic flexible bronchoscopy
  • Coagulopathy (PV INR >1.3)
  • Thrombocytopenia (<50x10^9) or anemia (hgb <80 g/L)
  • Direct oral anticoagulant, low molecular weight heparin or antiplatelet drug therapy
  • Thrombophilia, history of pulmonary embolism or deep vein thrombosis
  • Contraindication for endobronchial application of adrenaline
  • Coronary heart disease, cerebrovascular disease, history of tachyarrhythmia
  • Uncontrolled pulmonary hypertension
  • Cardiovascular decompensation
  • Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%)

Sites / Locations

  • Clinical Hospital Centre Zagreb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tranexamic acid

Adrenaline

Arm Description

Outcomes

Primary Outcome Measures

Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.

Secondary Outcome Measures

Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding
Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.
Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline
Recurrent bleeding episodes and hemoptysis requiring medical and/or bronchoscopic intervention.
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm in relation to the severity of bleeding.
As assessed by the bronchoscopist by visual analogue scale (VAS) 1-10 (1 very mild - 10 very severe).
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
In different indications and methods (transbronchial lung biopsy, endobronchial biopsy, transbronchial needle aspiration, bronchial brushing).
To compare number (N) of adverse events in each arm

Full Information

First Posted
February 18, 2021
Last Updated
February 22, 2022
Sponsor
Clinical Hospital Centre Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT04771923
Brief Title
Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding
Acronym
TAVA
Official Title
Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding: a Double Blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Centre Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Endobronchial bleeding is a relatively common complication of diagnostic bronchoscopy. Both tranexamic acid and adrenaline are used topically for the control of endobronchial bleeding. The aim of this study is to compare the efficacy of tranexamic acid with adrenaline in controlling iatrogenic endobronchial bleeding after diagnostic bronchoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Hemoptysis
Keywords
Bronchoscopy, Tranexamic acid, Adrenaline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Title
Adrenaline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.
Intervention Type
Drug
Intervention Name(s)
Adrenaline
Intervention Description
Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.
Primary Outcome Measure Information:
Title
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
Description
Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.
Time Frame
Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.
Secondary Outcome Measure Information:
Title
Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding
Description
Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.
Time Frame
Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..
Title
Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline
Description
Recurrent bleeding episodes and hemoptysis requiring medical and/or bronchoscopic intervention.
Time Frame
During the first 24 hours immediately after the individual procedure (bronchoscopy).
Title
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm in relation to the severity of bleeding.
Description
As assessed by the bronchoscopist by visual analogue scale (VAS) 1-10 (1 very mild - 10 very severe).
Time Frame
Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..
Title
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
Description
In different indications and methods (transbronchial lung biopsy, endobronchial biopsy, transbronchial needle aspiration, bronchial brushing).
Time Frame
Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.
Title
To compare number (N) of adverse events in each arm
Time Frame
During and up to 1 month after the procedure (bronchoscopy).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°C) normal saline (3 aliquots of 5ml during 60sec) Exclusion Criteria: Any patient with a contraindication for diagnostic flexible bronchoscopy Coagulopathy (PV INR >1.3) Thrombocytopenia (<50x10^9) or anemia (hgb <80 g/L) Direct oral anticoagulant, low molecular weight heparin or antiplatelet drug therapy Thrombophilia, history of pulmonary embolism or deep vein thrombosis Contraindication for endobronchial application of adrenaline Coronary heart disease, cerebrovascular disease, history of tachyarrhythmia Uncontrolled pulmonary hypertension Cardiovascular decompensation Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%)
Facility Information:
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Citations:
PubMed Identifier
36273651
Citation
Badovinac S, Glodic G, Sabol I, Dzubur F, Makek MJ, Baricevic D, Korsic M, Popovic F, Srdic D, Samarzija M. Tranexamic Acid vs Adrenaline for Controlling Iatrogenic Bleeding During Flexible Bronchoscopy: A Double-Blind Randomized Controlled Trial. Chest. 2023 Apr;163(4):985-993. doi: 10.1016/j.chest.2022.10.013. Epub 2022 Oct 21.
Results Reference
derived

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Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding

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